NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Technology Appraisals and Guidance Information Services Static List Review (SLR) report Title and TA publication number of static topic: Final decision: TA81: Frequency of application of topical corticosteroids for atopic eczema The guidance will remain on the static guidance list. 1. Publication date: August Date added to static list: December Date the last searches were run: June Current guidance: 1.1 It is recommended that topical corticosteroids for atopic eczema should be prescribed for application only once or twice daily. 1.2 It is recommended that where more than one alternative topical corticosteroid is considered clinically appropriate within a potency class, the drug with the lowest acquisition cost should be prescribed, taking into account pack size and frequency of application. 5. Research recommendations from 5.1 The trial literature is dominated by comparisons of differing frequency of use of fluticasone propionate (four trials) and comparisons of mometasone furoate with 1 of 11

2 original guidance: 6. Current cost of technology/ technologies: more traditional twice-daily treatment options (three trials). Trials are needed to establish whether once-daily use of the older (twice-daily) products is equivalent to more frequent use. Trials are also required to establish whether once-daily use of the older twicedaily products is equivalent to the once-daily-only products. Trials are required for all the potency classes, in particular for mild potency preparations, because no trials examining frequency of application of topical corticosteroids exist for this group. 5.2 Robust trials are required that report quality-of-life data and patient preferences. 5.3 Long-term follow-up is required in trials to assess adverse effects such as skin atrophy. 5.4 The experts informed the Committee that there was a lack of support for people with the condition and inadequate information about the management of atopic eczema and the risks associated with the use of topical corticosteroids. Research should therefore be conducted to establish the most suitable method of conveying high-quality information to people with atopic eczema. See Appendix Changes to the original indication: There have been no licence changes since the previous review proposal which are relevant to this appraisal. 8. New relevant trials: No new phase III or IV randomised controlled trials comparing frequency of application of corticosteroids were found. 9. Relevant NICE guidance (published Tacrolimus and pimecrolimus for atopic eczema. Technology Appraisal TA 82. Issued: 2 of 11

3 or in progress): August Static guidance. Alitretinoin for the treatment of severe chronic hand eczema. Technology Appraisal TA177. Issue: August Static guidance. Atopic eczema in children: Management of atopic eczema in children from birth up to the age of 12 years. Clinical Guideline CG57. Issued: December This guideline is currently being updated. The expected issue date for the updated guidance is September Grenz rays therapy for inflammatory skin conditions. Interventional Procedures Guidance IPG236. Issued: November Relevant safety issues: No relevant safety alerts were found. 11. Any other additional relevant information or comments: 12. Technical Lead comments and recommendation: None. No new evidence relating to the frequency of application of topical corticosteroids for atopic eczema was identified from the literature search carried out for this static list review. The list prices for most of the technologies have either increased or decreased slightly compared to those used in the original guidance TA 81. It is unlikely that these price changes will make any difference to the recommendations in TA 81 which states that where more than one alternative topical corticosteroid is considered clinically appropriate within a potency class, the drug with the lowest acquisition cost should be prescribed, taking into account pack size and frequency of application. A review would be unlikely to be considered good use of NHS resources because the recommendations would be unlikely to change. The consultation process will ensure that any additional evidence from stakeholders is considered. 3 of 11

4 SLR paper sign off: Janet Robertson Associate Director, Technology Appraisals Contributors to this paper: Technical Lead: Information Specialist: Project Manager: Nwamaka Umeweni Tom Hudson Andrew Kenyon Date of IS searching: 26 June of 11

5 Appendix 1 explanation of options Options Consequence Selected Yes/No The guidance will remain on the static guidance list The decision to review the guidance will be deferred to specify date or trial A full consideration of a review will be carried out through the Review Proposal Process The guidance will be withdrawn The guidance will remain in place, in its current form, unless NICE becomes aware of substantive information which would make it reconsider. Literature searches are carried out every 5 years to check whether any of the Appraisals on the static list should be flagged for review. NICE will consider whether a review is necessary at the specified date. NICE will actively monitor the evidence available to ascertain when a consideration of a review is more suitable. There is evidence that could warrant a review of the guidance. NICE will schedule a consideration of a review, including a consultation with relevant consultees and commentators. The guidance is no longer relevant and an update of the existing recommendations would not add value to the NHS. NICE will schedule a consideration of a review, including a consultation with relevant consultees and commentators. Yes No No No 5 of 11

6 Appendix 2 cost information BNF chemical name Mild Manufacturer Product name ( ) Net cost 1 per 30 g/30 ml for each strength 2 at the time of TA81 Current net cost 3 per 30 g/30 ml for each strength 4 (unless otherwise stated). Hydrocortisone 0.1 1% Actavis UK J. M. Loveridge Ltd. Cardinal Health Martindale Products Generic hydrocortisone cream (0.5%, 1%); ointment (0.5%, 1%) 0.66 (0.5% cream); 0.74 (1% cream) 0.65 (0.5% ointment); 0.76 (1% ointment) 2.90 (0.5% cream); 2.32 (1% cream) 4.90 (0.5% ointment); 2.58 (1% ointment) Marlborough Pharmaceuticals Pinewood Healthcare Reckitt Benckiser Amdipharm Teva UK Virtual Generics 1 BNF 47 March 2004 edition. 2 Calculated using the largest pack sizes available. For example, where 100 g is the largest pack size, the cost is calculated using the 100 g price multiplied by BNF online June 2013 edition. 4 Calculated as in footnote 2. 6 of 11

7 Virtual Specials Dermal Dioderm cream (0.1%) Astellas Mildison lipocream (1%) Fluocinolone acetonide Moderate Derma UK Synalar cream: 1 in 10 dilution (0.0025%) GSK Betnovate-RD cream or ointment (1 in 4 dilution of betnovate cream; ointment) (0.025%) (either formulation) Clobetasone butyrate GSK Eumovate cream or ointment (0.05%) (either formulation) Fludroxycortide Typharm Haelan cream or ointment (0.0125%); Haelan tape (4 micrograms/cm 2 ) cm 200 cm tape Alclometasone dipropionate Teva UK Modrasone cream (0.05%) Fluocinolone Derma UK Synalar cream or (either formulation) 7 of 11

8 Acetonide ointment: 1 in 4 dilution ( %) Fluocortolone caproate Meadow Ultralanum Plain cream or ointment (0.25%) (either formulation) Potent Beclometasone dipropionate Generic beclometasone dipropionate cream or ointment (0.025%) (either formulation) Actavis Manx Healthcare Teva UK Virtual Generics Generic betamethasone cream or ointment (0.1%) 1.54 (cream) 1.69 (ointment) 2.54 (cream) 2.80 (ointment). Dermal Betacap: watermiscible formulation for scalp application (0.1%) Genus Betesil medicated plasters (2.25 mg) n/a 9.92 (4 plasters) UCB Pharma Bettamousse foam for scalp application of 11

9 (0.12%) GSK Betnovate cream, ointment, lotion or water-miscible formulation for scalp application (0.1%) 1.31 (cream or ointment) 1.57 (lotion) 1.71 (scalp application) 1.22 (cream or ointment) 1.37 (lotion) 1.50 (scalp application) Fluticasone propionate GSK Cutivate cream (0.05%); ointment (0.005%) (either formulation) dipropionate Merck Sharp & Dohme Diprosone cream, ointment or lotion (0.05%) 2.05 (cream or ointment) 2.61 (lotion) 1.84 (cream or ointment) 2.34 (lotion) Mometasone furoate Merck Sharp & Dohme Elocon cream, ointment or scalp lotion (0.1%) 4.22 (cream or ointment) 4.88 (lotion) 3.77 (cream) 3.73 (ointment) 4.36 (lotion) Hydrocortisone butyrate Astellas Locoid cream, lipocream, ointment or scalp lotion (0.1%) 2.27 (cream or ointment) 3.15 (scalp lotion) 1.48 (cream or ointment) 1.55 (lipocream) 2.05 (scalp lotion) Hydrocortisone butyrate Astellas Locoid Crelo topical emulsion (0.1%) Fluocinonide Derma UK Metosyn FAPG cream 4.22 (cream, 25 g) of 11

10 or ointment (0.05%) 4.88 (ointment 25 g) 3.95 Mometasone furoate s Actavis UK Auden McKenzie Generic mometasone furoate ointment (0.1%) Glenmark Generics (Europe) Mylan UK Teva UK Virtual Generics Diflucortolone Meadow Nerisone cream, oily cream or ointment (0.1%) 1.59 (cream) 2.56 (ointment) 1.59 (cream or ointment) 2.56 (oily cream) Fluocinolone acetonide Derma UK Synalar cream, ointment or gel (0.025%) 1.74 (cream or ointment) 2.57 (gel) 3.53 (cream or ointment) 5.01 (gel) Very potent Clobetasol propionate Fabre Clarelux foam for scalp application (0.05%) Clobetasol propionate GSK Dermovate cream, ointment or scalp application (0.05%) 2.48 (cream or ointment) 3.27 (scalp application) 2.37 (cream or ointment) 3.13 (scalp application) 10 of 11

11 Clobetasol propionate Galderma Etrivex shampoo (0.05%) Diflucortolone Meadow Nerisone Forte oily cream or ointment of 11